The development pipeline of cell and gene therapies faces numerous obstacles while striving for the commercialisation of this impactful cutting-edge technology. The success of creating a cost-effective and high-quality product at a large scale to meet patient demand relies on a robust development phase. Strong research for a baseline mechanism of action is merely the start of a significant journey, as many companies struggle to deliver on the promise the research has predicted. While patient outcomes often seem groundbreaking – few cell and gene therapies have made it to market.
Economically, this life-changing space has a projected compound annual growth rate of 16.5% from 2023 to 2030 (Grand View Research 2021). With this in mind, companies looking to get a competitive advantage must look for ways to reduce the development timeline and effectively utilise their business assets. Finding a contract development and manufacturing organisation (CDMO) that can offer the entire product development pipeline, from translation to commercial supply, with strong experience and a proven track-record, is an effective approach to minimizing risk and maximizing value.
This is where Cell Therapies Pty Ltd’s unique selling point lies.
Cell Therapies is one of the most experienced GMP-compliant manufacturers of cell therapies, gene therapies, cellular immunotherapies, and regenerative medicine products globally (over 20 years). Our facility holds both commercial supply and clinical trial manufacturing licenses from multiple regulatory jurisdictions, such as Japan and Australia, and our team has significant expertise in supplying cell and gene therapy products for all phases of the clinical lifecycle through to commercial delivery.
The recent expansion of our facilities has allowed us to increase the throughput of late-phase clinical trial and commercial products, with an effective production capacity of up to 2,000 CAR-T patient doses per year. This additional capacity, alongside our existing ten (10) cleanroom facility that supports early-phase clinical trial development and GMP manufacturing, allows Cell Therapies to grow with companies as their products evolve from concept to commercialization.
Our skilled team of manufacturing operators are trained across different technology platforms, offering various solutions for cell isolation, selection, expansion, genetic modification, purification and more. Our analytical experts work with our clients to develop and implement test methods that ensure every patient’s product is carefully monitored and delivered to the highest standard.
Our robust quality management system ensures compliance with the desired regulatory standards but maintains flexibility during the clinical lifecycle to limit unnecessary restrictions. Our commitment to updating our operations to digital systems enable real-time access to process data enabling us to provide transparency to our clients. The patient is always at the forefront of their minds – knowing that each treatment, each action, is aiding in the development and research of this industry for the benefit of future patients.
Cell Therapies offers an effective and viable solution to long-term obstacles that this space has faced in translating research into commercialised products. This not only provides a competitive advantage to our clients, but our proven track record of consistent delivery has ensured results for patients.